1. Field of the Invention
The present invention relates generally to the field of healthcare. More specifically, the present invention relates to a predictive system and method for using a physician's existing client base to more effectively and efficiently identify potential candidates for new or little known medical treatments or clinical research trials.
Within the health care industry, and in particular within the field of clinical research, there is a need for a more effective process to identify and place candidates for clinical research trials to try new and improved products and services, including but not limited to new and/or potentially improved pharmaceutical products, medical devices, and procedures. Clinical trials are typically research studies conducted on volunteers to study the effectiveness of a new or improved medical product or service. The sponsor is typically the manufacturer of a drug or medical device and funds the clinical study, often as part of its FDA approval process. Sponsors can include pharmaceutical companies, clinical research organizations, medical device manufacturers, and site management organizations. An investigator is typically a research physician or group of physicians that actually conducts the clinical trial for the sponsor.
Volunteers that participate in a given clinical trial must meet certain criteria established by the sponsor and/or the investigator. Sample criteria may include type of disease, previous treatment history, other medical conditions that may be affected by participation in the study, age, and gender. Whether or not certain criteria are inclusive or exclusive typically depends on the nature of the clinical trial itself. Volunteers are carefully advised of the details of the clinical trial to ensure that they aware of both the positive potential impacts of participating in the study as well as the negative potential impacts of participating in the study.
Volunteers may participate in the clinical trial for various reasons, such as an opportunity to gain access to treatments that they otherwise could not because they are not on the market, have not been approved by the FDA, or could not afford, they may be motivated by the desire to contribute to medical research, or may simply be motivated to participate because of the money they are paid to participate.
It has been reported that the cost to bring a new drug to market can be one billion dollars. Because only approximately one in ten drugs are ever approved for market by the FDA, adjusting that number for current failure rates results in an estimated four billion dollars in research spent for every drug that is approved. A single clinical trial can cost one hundred million dollars. As a result, pharmaceutical companies must employ more effective and efficient methods of conducting clinical trials.
According to a Tufts University study, a pharmaceutical company can lose over a million dollars per day in lost drug sales for each day a clinical study is not complete. The clinical trial process can be slow and one of the main reasons is the time it takes to find a suitable population for the study. Sufficiently populating a clinical trial often takes more than a year and represents more than 25% of the entire length of the study lifecycle.
In addition to clinical trials, pharmaceutical companies, medical device manufacturers, and the like are constantly developing, improving, and discovering new medical treatments for medical conditions that may not be well known for the treatment of a certain condition. For example, some pharmaceutical products are not well known within the medical community because they are very expensive and, as such, are seldom used. However, there are often occasions when these drugs are highly effective for a certain condition but the medical provider is not familiar with the drug. There may be other instances where a medical device can be used to treat a condition but the device is not well known because FDA approval was not required. The medical device manufacturers have a need to identify potential candidates for its device and make the medical providers aware of its potential use.
2. Description of Related Art
A review of related art identifies various techniques that are currently used to identify suitable potential candidates for new or little known medical treatments or to participate in a clinical trial. The company or investigator may place advertisements, using various media such as newspaper, radio commercials, billboards, interact advertising, and the like, to find or solicit potential candidates. Information materials may also be given to specialist physicians for a related area of the medical treatment or clinical trial or to support groups for a specific condition. Success rates using these traditional methods are typically poor due to the inability to reach a large pool of potentially qualified candidates, and those that may be interested and do respond often do not meet the criteria to participate in the study.
Physicians are also often involved in referring patients to clinical trials. However, successful referral rates from physicians are not optimal either because physicians are usually extremely busy and have little time to study available clinical trials and assure their patients meet the necessary criteria for participation in a clinical trial.
In order to improve upon these traditional methods of identifying potential candidates for new or little known medical treatments or clinical research trials, various business efficiencies have been employed. For clinical trials, some use an online web-based system to screen potential candidates and match those candidates with various clinical research trials that the user may be qualified for. However, while these systems do improve upon the traditional methods to identify and recruit potential candidates for clinical research trials, these internet sites typically rely on information from a single source that does not have access to all information.
For example, some of these systems are directed to investigators and their database of patients they have worked with in the past. However, the investigator's information for its past patients is going to be stale and only specific to the clinical research trial that a patient may have been involved with in the past.
Other existing systems have the potential candidate complete a patient questionnaire to build a profile that will be compared against specific criteria for a clinical research trial. However, the potential candidates themselves will not know specific medical information such as the calcium level of a specific lab they had completed. This information is often kept with the physician.
Still other systems are directed toward physicians who are specialists in the area that is relevant to the clinical trial, such as an oncologist for clinical research trials involving cancer patients. These physicians typically depend on referrals from primary care physicians after a patient has been diagnosed, are treating patients with the latest technology that they have, and are extremely busy and have little time to fill out patient questionnaires. Further, these physicians cannot answer candidate specific questions such as whether a candidate plans on getting pregnant in the next six months.
A need exists, therefore, for an efficient and effective method and system to identify qualified potential candidates for new or little known medical treatments or clinical trials. A need also exists for a method and system of providing pertinent information related to the identified potential candidate such as answers to questions specific to the medical treatment or clinical trial, general demographic information, medical history, and medical records. A need also exists for a method and system to provide a more targeted search that will result in a higher percentage of qualified potential candidates for a specific medical treatment or clinical trial. The presented invention and embodiments thereof satisfy these needs.
All references cited herein are incorporated by reference to the maximum extent allowable by law. To the extent a reference may not be fully incorporated herein, it is incorporated by reference for background purposes and indicative of the knowledge of one of ordinary skill in the art.